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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
510(k) Number K172365
Device Name Panoramic Oxygen Mask (POM)
Applicant
Pom Medical, LLC
1230 Madera Rd., Suite 5, Box 101
Simi Valley,  CA  92065
Applicant Contact Jeff Voss
Correspondent
Pom Medical, LLC C/O Promedic, LLC
131 Bay Point Dr. NE
St Petersburg,  FL  33704
Correspondent Contact Paul Dryden
Regulation Number868.1400
Classification Product Code
CCK  
Date Received08/04/2017
Decision Date 04/19/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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